A Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Phase 1

• Conditions: Moderate to Severly Active Ulcerative Colitis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-504719-34-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

Documented diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline., Moderately to severely active UC as assessed by the modified mayo score, Demonstraed inadequate response to or intolerance of conventional (ie, 6-MP, AZA, or corticosteroids) or advanced therapy (ADT; ie, TNFa antagonists, vedolizumab, ozanimod, or approved JAK inhibitors).

Exclusion Criteria

1.Has severe extensive colitis as defined in the protocol, 2.Extent of inflammatory disease limited to the rectum, 3.Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD), 4.Has a history of, or ongoing, chronic or recurrent infectious disease, 5.Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 weeks prior to first dose of study intervention)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified